For regulatory, compliance, and quality consultancies the world over, demonstrating comprehensive capabilities comes down to showcasing work done for global innovators.

At IDEC, we’ve proudly supported more than 100 client projects, and we’ve worked with organizations across North America, Europe, the Middle East, and the Asia-Pacific region.

To learn more about our competencies applied to pharmaceutical industry needs, read two select success stories below.

Customer Success: Supporting a Pharmaceutical Company with the Development of a Global Product in Japan

A large US client with a global footprint was actively developing a drug product for sale on the global level. They intended to enter the Japanese market simultaneously with others around the world.

The client engaged IDEC’s R&D team in order to assess and account for Japanese regulatory requirements through their development process. Since then, IDEC has worked closely with various local constituents (KOLs, PMDA, CROs, and others) to implement the program for Japan.

IDEC began the design of the Japanese development program in 2010, and the client has utilized IDEC as a strategic partner across a broad spectrum of activities in various locations.

Our successful engagement moved in four stages:

Stage 1 Icon

Stage One

IDEC prepared an initial assessment report for the product development program that summarized opportunities and risk and prioritized a comprehensive list of indications to consider. The client utilized this report to initiate their product development program.

Stage 2 Icon

Stage Two

IDEC prepared an initial assessment report for the product development program that summarized opportunities and risk and prioritized a comprehensive list of indications to consider. The client utilized this report to initiate their product development program.

Stage 3 Icon

Stage Three

IDEC worked closely with the client to select and manage CROs to implement clinical trials in Japan. IDEC also led the selection and management of Key Opinion Leaders (KOLs) and the formation of an Advisory Board for the target disease area.

Stage 4 Icon

Stage Four

IDEC leveraged its in-house and external resources to prepare a comprehensive and compelling eCTD for Japanese submission. IDEC and the client collaborated closely to manage all inquiries from the PMDA across CMC, Non-Clinical, and Clinical areas.

What makes IDEC even more valuable to your business?

We’re part of the Validant family of companies, a global network that provides unrivaled access to full-lifecycle support.

Meet the Validant Family

Customer Success: Supporting a Japanese Client with the Development of a Product Licensed from Abroad

A mid-sized Japanese pharmaceutical company sought IDEC’s support with the development of a product bound for the Japanese market from the United States. Because of other commitments and a gap in specific expertise within the client’s ranks, IDEC was engaged to support R&D efforts and the development of a target compound.

IDEC’s relationship with the client began with a comprehensive Japanese development program design in 2009 and we remained a strategic partner across a range of unique activities until the program was approved in January of 2016.

Our successful relationship moved in four stages.

Stage 1 Icon

Stage One

IDEC prepared the initial assessment report for the client’s program—the program was not yet in-licensed by the client. The report demonstrated possible development scenarios in Japan for the client, and that led their decision-makers to move to in-license the program.

Stage 2 Icon

Stage Two

IDEC led the implementation of a PMDA consultation to confirm the development plan for the program in Japan. Due to the available data package from overseas, only minimal additional clinical and non-clinical data were required for the program to proceed in Japan.

Stage 3 Icon

Stage Three

IDEC collaborated with the client to select and manage CROs and testing sites. IDEC then implemented the additional studies for the Japanese regulatory requirements and led the selection and management of well-suited Key Opinion Leaders (KOLs) in the specified disease area.

Stage 4 Icon

Stage Four

IDEC leveraged both in-house and external resources to prepare a comprehensive eCTD for Japanese submission. Working closely with the client, IDEC managed all inquiries (CMC, Non-Clinical, and Clinical) from the PMDA through to complete product approval in January 2016.

Learn more about how IDEC can serve you.

Development Strategy Planning Icon

Development Strategy Planning

Learn More

Regulatory Consultation Icon

Regulatory Consultation

Learn More

Clinical Development Advisory Icon

Clinical Development Advisory

Learn More

Non Clinical Development Advisory Icon

Non-clinical Development Advisory

Learn More

Cmc Advisory Icon

CMC Advisory

Learn More

Application Preparation & Submission Icon

Application Preparation & Submission

Learn More

Kol Management Icon

KOL Management

Learn More

Regulatory Consultation Icon

Market Entry Planning

Learn More

Japanese Market Alignment Icon

Japanese Market Alignment

Learn More

Are you ready to streamline your entry into Japan with IDEC?

    I consent to IDEC's collection and processing of any personal information that I am submitting to IDEC in line with the company's privacy policy. Consistent with GDPR requirements, I understand that I have the right to withdraw such consent at any time.